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NCT07567313

PHASE4

Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous cell carcinoma.

Official title: Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study of Patients With Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2026-04-20

Completion Date

2028-06-30

Last Updated

2026-05-05

Healthy Volunteers

Conditions

Lung Squamous Cell Carcinoma Stage IV

Interventions

PROCEDURE

Immunotherapy combined with interventional therapy group

Tislelizumab 200mg, intravenous infusion, every 3 weeks, for 2 years. Simultaneously, the patient undergoes 1-3 sessions of transbronchial chemoembolization (BACE). A follow-up enhanced CT scan of the lungs and mediastinum is performed 4-6 weeks after BACE. Based on the results, the investigator will assess whether further BACE is necessary, with a maximum of 3 BACE sessions per patient.

DRUG

Immunotherapy group

Tislelizumab 200 mg, IV infusion, Q3W, maintenance for 2 years. Follow up with enhanced CT scans of the lungs and mediastinum every 4-6 weeks, and assess efficacy according to RECIST 1.1 criteria.

Inclusion Criteria: 1. Squamous cell carcinoma of the lung confirmed by histology or cytology; 2. According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV. 3. Has received standard first-line chemotherapy immunotherapy for 4\~6 cycles, and achieved partial remission or disease stability according to the efficacy evaluation of RECIST1.1; 4. The patient is 18-80 years old; 5. ECOG PS score is 0-1; 6. The main organ functions meet the following criteria: (1) Blood routine examination: hemoglobin (HB) ≥ 90g/L; Leukocyte (ANC) ≥ 3.0× 109/L; Neutrophils ≥ 1.5× 109/L; Platelet (PLT) ≥ 75× 109/L; (2) Biochemical examination: albumin (ALB)≥29g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2uln; Total bilirubin (TBIL) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN; 7. Patients and/or their families agree to participate in clinical trials and sign informed consent forms; 8. No history of other malignant tumors; 9. No active infection; 10. Be able to cooperate with research follow-up; 11. At least one measurable lesion (according to RECIST 1.1); 12. The expected survival time is more than 3 months. Exclusion Criteria: 1. There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation; 2. Have a history of allergy to contrast agents or chemotherapy drugs; 3. Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy; 4. Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women); 5. Coagulation function is seriously abnormal and cannot be corrected; 6. Hypertension patients still have poor blood pressure control (systolic blood pressure \> \>160mmHg, diastolic blood pressure \> 100 mmhg) after antihypertensive drugs treatment; 7. Pregnant or lactating female patients; 8. Have a history of mental illness or psychotropic drug abuse; 9. Patients with symptomatic brain metastasis; 10. Patients with autoimmune diseases;